Insmed Partners With Bill Thomas, Former House Ways and Means Chairman, as Strategic Advisor
17 Juillet 2008 - 2:00PM
PR Newswire (US)
Thomas Will Focus on Strategies to Promote Legislative Pathway for
Follow-On Biologics RICHMOND, Va., July 17 /PRNewswire-FirstCall/
-- Insmed Inc. (NASDAQ: INSM), a developer of follow-on biologics
and biopharmaceuticals for unmet medical needs, today announced
that The Honorable Bill Thomas, Former Chairman of the House Ways
and Means Committee from 2001 to 2007, has been retained by Insmed
as a strategic advisor to assist the Company's efforts to bring
follow-on biologics to U.S. customers and consumers. Bill Thomas
played a critical role developing key health legislation during his
28 years of service in the US House of Representatives, culminating
in the passage of the Medicare Modernization Act of 2003, which
created Medicare Part D prescription drug coverage for seniors.
"During my time in Congress I helped lay the groundwork to allow
biologic competition from follow-on biologics. I am excited to
partner with Insmed to continue that fight," said Chairman Thomas.
"Biotechnology represents the future of modern healthcare in
America, but as is the case across all industries in our economy,
competition will foster innovation and benefits for consumers,"
Thomas continued. "Insmed is walking the walk, having already
produced data showing bioequivalence between one of their products
and a pioneer drug. Given the rising costs of healthcare, Congress
needs to pass legislation creating a pathway for follow-on
biologics." The announcement follows Insmed's release of data last
week demonstrating bioequivalence between INS-19 and Neupogen(R)
(patented in 1996) in Phase I clinical trials. In the coming
months, Insmed will seek FDA approval to begin Phase III clinical
trials for INS-19 and also initiate Phase I trials for Insmed's
second follow-on biologic product, INS-20, a generic form of
Neulasta(R) (patented in 1998). The two biologics represented
combined 2007 worldwide sales of over $4 billion. Insmed plans to
launch its follow-on biologic versions of the innovator products
when the patents on the innovator products expire. "Chairman
Thomas' legislative expertise and strategic counsel will prove
invaluable in the coming months as Insmed continues in its mission
to be the first US-based biotechnology company to develop a
comprehensive portfolio of follow-on biologics products," said Dr.
Geoffrey Allan, President and CEO of Insmed. "We want to
demonstrate to Washington policymakers that the capability to
produce safe, effective and more affordable biologics exists today.
All that's needed is for Congress to create an approval pathway."
About Insmed Insmed Inc. is a biopharmaceutical company with unique
protein process development and manufacturing experience and a
proprietary protein platform aimed at niche markets with unmet
medical needs. For more information, please visit
http://www.insmed.com/ The Follow-on Biologics Market According to
published reports, an estimated $10 billion worth of biologic drugs
are expected to come off patent by 2010, with an additional $10
billion by 2015. FOBs would provide safe and effective therapies at
a reduced cost following the expiration of the original product's
patent. A recent econometric study by economist Dr. Robert J.
Shapiro, former Under Secretary of Commerce in the Clinton
Administration, found that "...generic versions of the top 12
categories of biologic treatments with patent protections that have
expired or that are due to expire in the near future could save
Americans $67 billion to $108 billion over 10 years and $236
billion to $378 billion over 20 years." Forward-Looking Statements
This release contains forward-looking statements which are made
pursuant to provisions of Section 21E of the Securities Exchange
Act of 1934. Investors are cautioned that such statements in this
release, including statements relating to planned clinical study
design, regulatory and business strategies, strategic alternatives,
plans and objectives of management and growth opportunities for
existing or proposed products, constitute forward-looking
statements which involve risks and uncertainties that could cause
actual results to differ materially from those anticipated by the
forward-looking statements. The risks and uncertainties include,
without limitation, risks that strategic alternatives may never be
consummated, product candidates may fail in the clinic or may not
be successfully marketed or manufactured, we may lack financial
resources to complete development of product candidates, the FDA
may interpret the results of studies differently than us, competing
products may be more successful, demand for new pharmaceutical
products may decrease, the biopharmaceutical industry may
experience negative market trends, our entrance into the follow-on
biologics market may be unsuccessful, our common stock could be
delisted from The NASDAQ Capital Market and other risks and
challenges detailed in the Company's filings with the U.S.
Securities and Exchange Commission, including the Company's Annual
Report on Form 10-K for the year ended December 31, 2007. Readers
are cautioned not to place undue reliance on any forward-looking
statements which speak only as of the date of this release. The
Company undertakes no obligation to publicly release the results of
any revisions to these forward-looking statements that may be made
to reflect events or circumstances that occur after the date of
this release or to reflect the occurrence of unanticipated events.
Investor Relations Contact: Brian Ritchie - FD 212-850-5683 Matthew
Duch - FD 212-850-5758 Corporate Communications Contact: John
Procter - Gibraltar Associates 202-879-5808 DATASOURCE: Insmed Inc.
CONTACT: Investors: Brian Ritchie, +1-212-850-5683, , or Matthew
Duch, +1-212-850-5758, , both of FD, or Corporate Communications:
John Procter of Gibraltar Associates, +1-202-879-5808, , all for
Insmed Inc. Web site: http://www.insmed.com/
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